Spatially Fractionated Radiation Treatment for Gynaecological Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorTata Memorial Hospital
About this trial
This is a prospective study to evaluate in-field disease control, survival and late toxicity in patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT.
The study will include patients with primary cervical cancer or pelvic recurrence not suitable for brachytherapy in view of anticipated or actual suboptimal target coverage due to aberrant anatomy or large residual disease at the time of brachytherapy.
Eligibility criteria
Qualifiers
Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-
Aberrant uterine or pelvic anatomy leading to difficulty in localization of the cervical OS or negotiation of the uterine canal accurately by two independent clinicians in up to two procedures.
Large residual disease at the time of brachytherapy with anticipated suboptimal target coverage either determined in clinic based on pre-brachytherapy imaging or at dose planning (e.g. figure 2).
Very narrow vaginal canal not accommodating even the smallest intracavitary or vaginal cylinder applicators.
Disqualifiers
Any pre-existing fistula in bladder or rectum.
Pelvic prosthesis.
Refusal to provide consent.
Trial design
Treatments tested in this trial
- Spatially fractionated radiation therapy
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov